The Food and Drug Administration (FDA) is warning consumers not to use unapproved home-use diagnostic test kits that have been marketed nationwide via the Internet by Globus Media,
Rapid HIV Test Kit
Rapid Syphilis Test Kit
One Step Cassette Style Cocaine Test
One Step Cassette Style Marijuana (THC) Test
One Step Cassette Style Amphetamine Test
Rapid Dengue Fever Test
One Step Midstream Style HCG Urine (Home)
FDA learned of the problem from two consumer complaints.
FDA has not approved or evaluated the performance of any of Globus Medias products. As a result, consumers cannot know with any degree of certainty that test results are correct. For example, a person testing positive for HIV (human immunodeficiency virus, or the AIDS virus) using one of these tests may not be infected with HIV, or, worse, someone infected with HIV may test negative and not seek medical treatment or spread the virus to others.
The tests were sold through web sites and distributed throughout the
Consumers who have these products should not use them. Anyone who has used one of these test kits should be retested using valid test methods.
The FDA has issued an import alert which alerts FDA field personnel to the possible importation of these devices, provides guidance as to their detention and refusal of admission into the